How the TGA regulatesThe TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts

TGA internal review guidelineThis guideline provides information on the operation of internal review in TGA, and guidance on how to apply under section 60 of the Therapeutic Goods Act 1989, to have an initial decision of a TGA delegate reviewed